FDA OKs device that helps improve vision lost to retinal disease

The FDA on Thursday approved a bionic eye that improves vision for patients blinded by a rare eye condition called retinitis pigmentosa. The Argus II system, a video camera and transmitter mounted on eyeglasses, translates light and movement into electrical signals, which are sent directly to an array of electrodes implanted into a patient's retina.

Clinical trials have demonstrated that for patients whose retinal cells have been ravaged by the genetic condition, the visual prosthetic device helps restore the ability to perform many daily activities. In its current form, the device does not restore vision, but allows patients to detect light and dark in their visual field.

Patients who were unable to perceive even bright lights reported that after receiving the implantable device, they were able to see large letters, to locate people and simple objects, and to detect movement in their field of vision.

The Argus II, built by Sylmar, Calif.-based Second Sight Medical Products Inc., breaks new ground in devices to assist the visually impaired. The gadget took more than two decades to develop, and Second Sight got early funding from the Department of Energy, the National Science Foundation and the National Eye Institute to develop it. It is the first of many visual prosthetic devices under development, but the first to have demonstrated the capability to hold up under long-term implantation in the human eye.

While millions of Americans have lost their sight to more common conditions such as macular degeneration, diabetic retinopathy and glaucoma, the FDA approved the Argus II for a smaller patient population that has progressively lost peripheral, night and central vision as the light-sensitive photoreceptors on the retina have degenerated. An estimated 100,000 people in the United States suffer from retinitis pigmentosa, a condition passed down by gene mutations inherited from one or both parents.

Starting later this year, eye surgeons at seven sites in the United States, including the Doheny Eye Institute in Los Angeles and at UC San Francisco Medical Center, will begin implanting the Argus II system. The device was approved for use in Europe last year, and costs about $115,000.